Asbestos contamination of parenteral drugs

Our plain-English summary of Asbestos contamination of parenteral drugs, by W.J. Nicholson, C.J. Maggiore, I.J. Selikoff (Science, 1972).

The study

• Authors: W.J. Nicholson, C.J. Maggiore, I.J. Selikoff
• Journal: Science
• Published: 1972;177(4044):171-3
• Cited by: 40 articles, as counted by NIH iCite
• Read it: PubMed · Publisher
• In J-M's library: Johns-Manville's company medical library held a copy (J-M no. 002430).

Abstract

Chrysotile asbestos has been found in approximately one third of the samples from two sets of 17 widely used parenteral drugs.

In plain English

This short report from the Mount Sinai School of Medicine in New York tested injectable (parenteral) drugs for asbestos. The authors noted that chrysotile was the asbestos variety drug makers chose for filters. They took single-dose vials of widely used injectable drugs from the Mount Sinai Hospital pharmacy in 1969 and again about a year later. They filtered the contents and searched for chrysotile asbestos by optical and electron microscopy, using filtered sterile water as controls. In 1969, 16 samples were scanned by optical microscope. Six of them, plus a duplicate, were then checked by electron microscope, and 5 of these 7 had asbestos levels several times those of the controls. In the second set, asbestos in 6 of 17 samples significantly exceeded background levels. Some samples were estimated to contain more than a microgram of asbestos. The authors concluded that finding asbestos in one third of the vials indicated significant contamination of some parenteral drugs at that time. They cautioned that one vial cannot represent a whole production run, that a negative result does not guarantee absence, and that only a small fraction of marketed drugs was sampled.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Laboratory analysis of drug samples by optical and electron microscopy, with filtered sterile water controls
• Who was studied: Single-dose vials of widely used injectable drugs from the pharmacy stock of Mount Sinai Hospital (New York), collected in 1969 and again about 1 year later (fall 1970 and spring 1971)
• Exposure: Chrysotile asbestos in injectable drug solutions. The authors noted that chrysotile was the asbestos variety of choice for pharmaceutical filters.
• Main results:
  • In 1969, 16 drug samples were scanned by optical microscope, and all fibers longer than 5 micrometers were recorded
  • Of 7 samples from 1969 checked by electron microscope (6 samples plus one duplicate), 5 had asbestos concentrations several times those in background controls. These 5 included all samples in which asbestos had been identified optically.
  • In the second set of samples (fall 1970 and spring 1971), asbestos in 6 of 17 samples significantly exceeded background levels
  • The estimated amounts of asbestos in some samples exceeded a microgram. The authors described these amounts as much higher than those reported for other environmental circumstances.
  • The filtered samples also contained many fibers and particles other than asbestos
• The authors' conclusion: The authors concluded that finding asbestos in one third of the single vials examined over a 1-year period indicated significant asbestos contamination of some parenteral drugs at that time
• Limitations the authors state:
  • A single vial is an inadequate sample of a large production run
  • A negative or unclear result for a sample does not guarantee that the drug lot it came from is free of asbestos
  • The drugs sampled were only a small fraction of those on the market
  • Optical microscopy could identify chrysotile with reasonable assurance only for fibers longer than about 100 micrometers. Many fibers consistent with asbestos could not be reliably identified and were not recorded as asbestos.

Topics

Medical terms in this study, explained in our Lexicon: Chrysotile.

Related studies

• A potential cause of asbestos-related granulomatosis due to adulterant contamination in a drug abuser — M.C. Lazzaro, S. Romanò, et al. (2021)
• Asbestos fibers in parenteral medication — J. Addison, K. Browne, et al. (1993)
• Inorganic particle content of foods and drugs — W.V. Eisenberg (1974)
• Evaluation by electron microscopy techniques of asbestos contamination in industrial, cosmetic, and pharmaceutical talcs — L. Paoletti, S. Caiazza, et al. (1984)
• Simian virus 40, poliovaccines and human tumors: a review of recent developments — M. Carbone, P. Rizzo, et al. (1997)
• The contamination of Lake Superior with amphibole gangue minerals — A.M. Langer, C.M. Maggiore, et al. (1979)

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